510(k) Report

Devices descending from K121979

14 later devices reach Pass Oct Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150918PASS OCT Spinal SystemMedicrea International SA201513—
+2K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+2K161149PASS OCT Spinal SystemMedicrea International SA20160—
+2K160756PASS OCT Spinal SystemMedicrea International SA20160—
+2K153169PASS OCT Patient Specific RodsMedicrea International20164—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—